(86 days)
DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of patients with Type 1 diabetes who:
· use insulin pumps as their insulin delivery therapy;
· monitor their glucose levels using continuous glucose monitoring (CGM) and/or Self-Monitoring Blood Glucose (SMBG) meter;
• are above the age of 6; and
· use rapid acting U-100 insulin analogs in their pump
DreaMed Advisor Pro is indicated for use by healthcare professionals when analyzing CGM, SMBG and pump data to generate recommendations for optimizing a patient's insulin pump settings for basal rate, Carbohydrate Ratio (CR), and Correction Factor (CF); without considering the full clinical status of a particular patient. DreaMed Advisor Pro does not replace clinical judgement.
DreaMed Advisor Pro is a software device that is designed to provide insulin therapy adjustment recommendations to physicians to assist in the management of diabetes for patients with Type 1 diabetes using an insulin pump, a continuous glucose monitoring (CGM) system and self-management blood glucose meter (SMBG).
The DreaMed Advisor Pro gathers and analyzes information inputted through qualified Diabetes Management Systems (DMS), which collects biological input information from various diabetes devices. Diabetes device information required and used by DreaMed Advisor Pro includes glucose readings (either CGM sensor readings and/or capillary blood glucose measurements), insulin dosing logs, and meal data during daily routine care.
Following data collection and analysis, the DreaMed Advisor Pro generates results containing summary data and recommendations for adjustments to the patient's insulin therapy parameters, including basal insulin delivery rate(s), insulin to carbohydrate ratio and correction factor (insulin sensitivity). DreaMed Advisor Pro may also advise behavioral changes. Results are sent to a qualified Diabetes Management Systems, which displays results to physicians and a report provided by DreaMed Diabetes. The physician can approve, reject or change the recommendations and issue the updated treatment plan to the patient.
The provided text is a 510(k) summary for the DreaMed Advisor Pro, which is a software device intended to assist healthcare professionals in managing Type 1 diabetes. It primarily describes the device, its intended use, and argues for its substantial equivalence to a previously cleared version of the same device (K191370).
However, the document does not contain the detailed information requested about acceptance criteria, specific study results, sample sizes for test and training sets, expert qualifications, adjudication methods, or MRMC comparative effectiveness studies. It simply asserts that the updated DreaMed Advisor Pro is "as safe and effective" as the previously cleared one, with the only change being an expansion of the age range to include patients over 65.
Therefore, I cannot populate the table and answer all the questions based on the provided text. I will indicate where the information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric, Threshold) | Reported Device Performance |
|---|---|
| Not provided in the document. The document asserts substantial equivalence to a predicate device rather than detailing specific performance criteria or the results of a new study proving these. | Not provided in the document. No specific performance metrics or thresholds are given, nor are results of a study designed to meet such criteria. |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not provided in the document.
- Data provenance: Not provided in the document. No specific study data is presented, so the origin (country, retrospective/prospective) of any potential test data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the document. Since no specific test set study is detailed, there's no information on ground truth establishment or expert involvement.
4. Adjudication method for the test set
Not provided in the document.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not provided in the document. The submission focuses on substantial equivalence to a previous version of the same AI device, not on comparing human readers with and without the AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as "decision-support software intended for assisting healthcare professionals," and states that "DreaMed Advisor Pro does not replace clinical judgement." This implies human-in-the-loop operation. No standalone (algorithm-only) performance is described or implied to have been studied for this 510(k) submission.
7. The type of ground truth used
Not provided in the document. No specific ground truth methodology is mentioned as a study proving performance is not detailed in this submission.
8. The sample size for the training set
Not provided in the document.
9. How the ground truth for the training set was established
Not provided in the document.
§ 862.1358 Insulin therapy adjustment device.
(a)
Identification. An insulin therapy adjustment device is a device intended to incorporate biological inputs, including glucose measurement data from a continuous glucose monitor, to recommend insulin therapy adjustments as an aid in optimizing insulin therapy regimens for patients with diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include the following:
(i) A complete description of the required data inputs, including timeframe over which data inputs must be collected and number of data points required for accurate recommendations;
(ii) A complete description of the types of device outputs and insulin therapy adjustment recommendations, including how the recommendations are generated;
(iii) Robust data demonstrating the clinical validity of the device outputs and insulin therapy recommendations;
(iv) A robust assessment of all input data specifications, including accuracy requirements for continuous glucose monitors and other devices generating data inputs, to ensure accurate and reliable therapy adjustment recommendations. This assessment must include adequate clinical justification for each specification;
(v) A detailed strategy to ensure secure and reliable means of data transmission to and from the device, including data integrity checks, accuracy checks, reliability checks, and security measures;
(vi) Robust data demonstrating that users can understand and appropriately interpret recommendations generated by the device; and
(vii) An appropriate mitigation strategy to minimize the occurrence of dosing recommendation errors, and to mitigate the risk to patients of any residual dosing recommendation errors to a clinically acceptable level.
(2) The device must not be intended for use in implementing automated insulin dosing.
(3) Your 21 CFR 809.10(b) labeling must include:
(i) The identification of specific insulin formulations that have been demonstrated to be compatible with use of the device;
(ii) A detailed description of the specifications of compatible devices that provide acceptable input data (e.g., continuous glucose monitors, insulin pumps) used to provide accurate and reliable therapy adjustment recommendations;
(iii) A detailed description of all types of required data (inputs) and dosing recommendations (outputs) that are provided by the device; and
(iv) A description of device limitations, and instructions to prevent possible disruption of accurate therapy adjustment recommendations (e.g., time zone changes due to travel).